Kornimate/medical-research-clean huggingface dataset:
perioperative outcomes of simultaneous colorectal and liver resections

Conditions: Colorectal Cancer Metastatic; Surgical Procedure, Unspecified

Summary: the use of a simultaneous resection in patients with synchronous colorectal liver metastases has increased over the past decades. however, it remains unclear when a simultaneous resection is beneficial and when it should be avoided. the objective of this retrospective study is therefore to compare the outcomes of a simultaneous resection for synchronous colorectal liver metastases in different settings, and to assess which factors are independently associated with unfavorable outcomes.


Eligibility criteria:
inclusion criteria: * elective minimally invasive or open simultaneous resection of colorectal cancer and synchronous colorectal liver metastases exclusion criteria: * (partially) robotic-assisted or thoracoscopic procedures * first stage of associating liver partition and portal vein ligation for staged hepatectomy (alpps) * patients that underwent major concurrent procedures

Keywords: colorectal cancer synchronous colorectal liver metastases simultaneous resection postoperative outcomes
efficacy of calcium silicate pulp-capping; a randomized controlled clinical trial

Conditions: Reversible Pulpitis

Summary: this study aims to investigate the tooth nerve response to a recently introduced therapeutic filling material (calcium silicate cement) called biodentine and to assess the quality of the overlying filling compared to another material (glass ionomer cement) called fuji ix used more commonly. also to compare the effectiveness of cone beam computed tomography x-rays compared to conventional periapical x-rays in detecting lesions around these teeth.

tooth decay is one of the most widespread diseases in the world. very often, a patient comes to the dental clinic when experiencing pain which commonly means the decay is deep and is very close to or has penetrated the nerve of the tooth. when the decay is very close to the pulp or nerve of the tooth, a procedure called pulp capping is done in an attempt to save the tooth and to prevent root canal treatment. a material has been introduced to the market for this purpose, called biodentine. this study aims to investigate the nerve response to this material and to assess the quality of the overlying filling compared to another material (glass ionomer cement) used more commonly. also, x-rays are a routine procedure used to assess how close the decay is to the nerve and to see if there are abnormalities around the tooth. however conventional x-rays may not be accurate. a new technique called cone beam computed tomography (cbct) has been developed which shows a 3-d image of the tooth and may be more accurate. we aim to compare the images gained from conventional x-rays and cbct to help improve diagnosis and care planning for patients.

Eligibility criteria:
inclusion criteria: 1. patients either male or female over the age of 16 (who can consent for themselves) in good general health 2. a minimum of one carious lesion (occlusal, proximal, or mod) 3. positive pulp response to electric pulp test and thermal stimulation. exclusion criteria: 1. patients with clinical symptoms of irreversible pulpitis who need root canal treatment 2. the presence of fistulas or swelling 3. anterior teeth with aesthetic concerns 4. external or internal root resorption 5. multiple teeth with carious lesions in the same quadrant, 6. mobile teeth or tenderness to percussion. 7. pregnant women, in view of requirements for radiographs. 8. patients younger than 16. 9. patients unable to give consent

Keywords: indirect pulp capping reversible pulpitis periapical radiolucency periapical radiographs cone beam computed tomography calcium silicate cements glass ionomer cements caries
multidisciplinary shared decision making of fertility preservation in young women with breast cancer

Conditions: Young Womenwith Breast Cancer

Summary: multidisciplinary shared decision making of fertility preservation in young womenwith breast cancer (mybc): a pragmatic stepped wedge cluster randomised trial


Eligibility criteria:
inclusion criteria: * women aged 19 to 40 years old * a person diagnosed with breast cancer by biopsy * those who don't have evidence of distant metastasis * eastern cooperative oncology group(ecog) performance status: 0-2 score * before registering for clinical trials, chemotherapy, radiation therapy, anti-hormone therapy, immunotherapy, and surgery are not performed * a person who has fully understood and listened to the explanation of this clinical trial and then gave written consent exclusion criteria: * histologically, a person diagnosed with follicular or sarcoma * those with a history of breast cancer (including recurrent breast cancer) * a person diagnosed with another cancer before breast cancer * a person diagnosed with metastatic breast cancer * a person who has a mental illness and has a hard time understanding clinical trials * those who plan to conduct follow-up observation elsewhere(to change of hometowm) * menopausal factors without menstruation after more than a year from the last menstrual date * a pregnant woman * inappropriate for participation in clinical trials
risedronate in the prevention of osteoporosis in postmenopausal women

Conditions: Osteoporosis, Postmenopausal

Summary: primary objective: * to demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (bmd) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. secondary objectives: * to demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter bmd after 1 year of treatment in women who are 0.5-5 years postmenopausal * to assess the general safety of 35-mg risedronate administered once weekly.


Eligibility criteria:
the following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. this information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. main inclusion/exclusion criteria are listed hereafter: inclusion criteria: * be postmenopausal for 0.5-5 years.menopause is defined as 12 months without menses, based on medical history. subjects who are post-menopausal secondary to bilateral oophorectomy must have serum fsh \>40 miu/ml and estradiol \<20 pg/ml. * subjects with 3 contiguous lumbar spine vertebral bodies (l1-l4) without fracture or degenerative disease. * lumbar spine bmd mean value \> 0.772g/cm2 (hologic) or \>0.880 g/cm2 (lunar). exclusion criteria : * subjects with adequate lumbar spine bmd but osteoporotic by total proximal femur bmd (\<0.637 g/cm2 \[hologic\]) or \<0.694 g/cm2 \[lunar\]) as determined by dual-energy x-ray absorptiometry (dxa)
the effect of administering a small dose of glucose during cesarean section

Conditions: Cesarean Section

Summary: the purpose of this study is to investigate the effect of administering a small dose of glucose on the pregnant women and their neonates during cesarean section. we investigate the safety and efficacy of use of a glucose-containing solution for the pregnant women and the neonates.

rapid infusion of large amount of glucose is associated with fetal hyperglycemia, hyperinsulinemia, and neonatal hypoglycemia. however, the effect of small dose of glucose is unclear. we conducted a pilot study of small dose of glucose. we investigated the effect of a glucose-containing fluid on the blood sugar of the umbilical artery. we found that in the case of no-glucose-containing fluid, there were some cases in which umbilical arterial concentration of glucose was less than 50 mg/dl, which might cause neonatal hypoglycemia. in addition, in the case of 1%-glucose-containing fluid, mean umbilical arterial concentration of glucose was 97 mg/dl. the purpose of this study is to investigate the effect of administering a small dose of glucose on the pregnant women and their neonates during cesarean section. we investigate the safety and efficacy of use of a glucose-containing solution for the pregnant women and the neonates.

Eligibility criteria:
inclusion criteria: * patients undergoing cesarean section who met the criteria of the american society of anesthesiologists physical status of 1-2 exclusion criteria: * asa physical status \>=3, obesity (bmi\>35), height\>=175cm, weight\>=80kg

Keywords: cesarean section intravenous fluid a glucose-containing solution fetal hypoglycemia neonatal hypoglycemia
adalimumab in alleviating inflammation in patients with axial spondyloarthritis

Conditions: Ankylosing Spondyloarthritis

Summary: axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the spine and the sacroiliac joints. inflammatory pathways are likely the central link from axial spondyloarthritis to the known increased risk of atherosclerotic morbidity. positron emission tomography (pet) is the most sensitive method to detect inflammatory foci in clinical practice. a few small studies have demonstrated that pet imaging together with computed tomography (pet/ct) detects inflamed tissues in relevant patient groups. one study suggested that antirheumatic treatment diminishes the inflammation detected in pet/ct. no study so far has disclosed whether aortic inflammation is present in patients with spondyloarthritis, and whether the inflammation would wane with efficient antirheumatic treatment. the current study is aimed to grade the articular and aortic inflammatory signals in the pet/ct imaging before and after antirheumatic treatment of clinically active axial spondyloarthritis. sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as detected either by mri or x-ray will be recruited. twenty of those are dmard-naive, and 40 patients have axial spondyloarthritis resistant to sulfasalazine or other conventional antirheumatic drug. in addition, approximately 30 patients without spondyloarthritis but with stable coronary heart disease and approximately 20 healthy controls will be taken as historical controls. all the axial spondyloarthritis patients are pet/ct scanned after inclusion in the study. the dmard-naive patients (n=20) are started sulfasalazine-based regimen for 12 weeks, which is the time point for a second pet scan for this subgroup. adalimumab will be commenced for those without remission at 12 weeks. after another 16 weeks, those with adalimumab will be scanned with pet/ct for the third time. the subgroup with active disease in spite of prior conventional treatment (n=40) is also scanned with pet/ct right after the enrolment and after 16-week treatment with adalimumab. the first 15 patients form a pilot group, which is used to check the validity of the power calculation. the project will give essential new information on pet-detectable inflammation in the patients with axial spondyloarthritis. the results will be published in international publication series. the publications will form the basis for a doctoral thesis. funding for the project comes from abbvie ltd.


Eligibility criteria:
inclusion criteria: * axial spondyloarthritis (asas criteria) and radiologic sacroiliitis as detected either by mri or x-ray. exclusion criteria: * psoriasis or psoriasis arthropathy * inflammatory bowel disease * unwillingness to participate in the study with additional imaging protocols * expected life-span less than \<1 year * diabetes (to improve the pet imaging quality) * probable noncompliance * pregnancy * age \ 75 years * contraindication for adalimumab * methotrexate used within the previous 6 months * a biologic medicine used within the previous 6 months
live biotherapeutic product gb104 phase 1 study in colorectal cancer

Conditions: Solid Tumor; Colorectal Cancer; Sigmoid Colon Cancer; Rectosigmoid Junction Cancer; Cancer; Rectal Cancer

Summary: prospective, open label, multi-dose, sequential dose escalation, single-center, phase 1 trial

this is a single center, open-label, phase 1 study to evaluate the safety and tolerability of gb104 and explore gut microbial composition in patients with colorectal cancer who completed standard treatment including curative colectomy with or without full-cycle adjuvant chemotherapy. gb104 is a live biotherapeutic product consisting of a lyophilized formulation of a single strain of bacterium. the dosing regimen for the study involves the oral administration of the experimental drug once a day.

Eligibility criteria:
inclusion criteria: 1. subjects who sign on an informed consent form willingly 2. subjects who have histological and radiological diagnosis of colorectal cancer 3. males and females aged between 19 and 80 years at the time of screening 4. subjects who have undergone radical colectomy and received the following treatments before participating in the clinical trial, and have completed the specified period: * subjects who have received adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy and have completed 3 months since the last treatments * subjects who have not received any adjuvant therapy and have completed 3 months from the radical colectomy * subjects who have undergone stoma closure and have completed 3 months after stoma closure 5. subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of gb104 6. subjects who have received adjuvant chemotherapy or radiation therapy, and have completed 3 months after completing the treatment, and toxicity from previous adjuvant treatment must have recovered to nci-ctcae v5.0 grade 1 7. subjects who have been confirmed to have adequate hematological, renal, and hepatic function at the screening point (laboratory tests may be retested during the screening period) 8. female subjects of childbearing potential and sexually active men who agree to abstain from sexual activity or use an adequate method of contraception exclusion criteria: 1. significant cardiac dysfunction, new york heart association classification for chronic heart failure iii-iv, symptomatic coronary artery disease, significant deep vein thrombosis; myocardial infarction within 6 months 2. severe active infections that require systemic antibiotics, antifungal agents, antiviral agents, or other medications that cannot be controlled 3. previous history of immunosuppressant within the 1 month of initial administration 4. known hiv infection, or active infection with hepatitis b or c 5. subjects who have completed a course of antibiotics within the one month prior to screening
a phase 1 single and multiple-dose study of aramchol in healthy male volunteers

Conditions: Healthy

Summary: a phase 1, randomized, double-blind, placebo-controlled, escalating single and multiple-dose study of aramchol in healthy male volunteers. primary objectives: 1. to assess and characterize the safety and tolerability of aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (part a) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (part b) 2. to assess the pharmacokinetics of aramchol at the administered doses

number of subjects: total: a total of 46 healthy subjects will be enrolled. part a: sixteen (16) subjects will participate in four, 8-person dosing periods. each cohort will be alternately dosed twice. part b: thirty (30) subjects will be enrolled in two, 15-person dose-ascending cohorts. main inclusion criteria: part a: healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent part b: mildly overweight (25\<bmi\<33), with fasting cholesterol levels of 200-300 mg/% or ldl 100-180 mg/% and triglycerides \< 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent

Eligibility criteria:
inclusion criteria: * part a: healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent * part b: mildly overweight (25\<bmi \<33), with fasting cholesterol levels of 200-300 mg/% or ldl 100-180 mg/% and triglycerides \< 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent major exclusion criteria: * history of significant neurological (including history of seizures or eeg abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications. * history of drug or alcohol abuse. * known allergy to any drug. known allergy to any drug. * clinically significant abnormalities found in the screening physical exam. * significant abnormalities in clinical laboratory parameters (hematology, biochemistry, urinalysis) determined within 40 days of the start of the study and on day (-1) before first dosing session. parameters to be measured are those shown in appendix 2.

Keywords: phase-i hypercholesterolemia obesity fatty liver part a: healthy male volunteers part b: mildly overweight, otherwise healthy hypercholesterolemic male volunteers
prizma device temperature measurement

Conditions: Temperature Change, Body

Summary: the purpose of the study is to evaluate the temperature measurements by the prizma device.

primary objective of this study is to compare the temperature measured by the prizma to the oral and armpit temperature measured by a gold standard device in order to develop and evaluate a skin to body temperature conversion table. secondary objective is to collect and compare data of ecg, respiration and spo2 collected from the prizma device to the data collected from gold standard devices for reference of noise level and for future development of the prizma device.

Eligibility criteria:
inclusion criteria: * signed written informed consent * age above 18 years from both genders * asa physical status 1-4 * hospitalized in internal ward exclusion criteria: * abuse of alcohol or illicit drugs * history of mental retardation or any mental disease * skin irritation / atopic dermatitis or any other skin condition at the area of patients palms that might affect his/her ability to hold the device appropriately
safety and performance of the cavu medical, inc. attune tubing study

Conditions: Obesity

Summary: the objectives of this clinical research project are to demonstrate the safety and feasibility of cavu medical, inc.'s attune device.


Eligibility criteria:
inclusion criteria: 1. the subject is at least 18 years of age. 2. the subject has been informed of the nature of the trial and agrees to its provisions. 3. the subject has a pre-implantation bmi within the protocol limits. 4. the subject agrees to the follow-up visit schedule. 5. the subject is a candidate for a lagb procedure. 6. the subject agrees to comply with specified follow-up evaluations. 7. the subject is willing to fast for 2 hours prior to each adjustment visit. exclusion criteria: 1. the subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial. 2. the subject has a condition that is contraindicated for lagb procedures. 3. the subject is currently using weight loss medications or supplements. 4. the subject has a concurrent terminal medical condition with a life expectancy of less than 12 months. 5. the subject is currently participating in an investigational drug or another medical device trial. 6. the subject had a previous lagb procedure. 7. the investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.
chronic heart failure analysis and registry in the tohoku district 2 (chart-2 study)

Conditions: Heart Failure; Coronary Disease; Heart Valve Diseases; Cardiomyopathies; Left Ventricular Hypertrophy

Summary: chronic heart failure analysis and registry in the tohoku district 2 (chart-2 study) is a large, prospective, hospital-based cohort study to investigate the following: * characteristics of patients with chronic heart failure and prognostic risks of these patients. * characteristics of patients with high risk for heart failure and critical factors which predict the development of symptomatic heart failure in these patients. * the incidence and prognostic impact of metabolic syndrome in patients with chronic heart failure. * the association between metabolic syndrome and the development of symptomatic heart failure.

the chart-2 study is a multicenter prospective observational cohort study identifying the characteristics, mortality and prognostic risks of patients with overt hf and patients without hf but who are at high risk for disease progression of cardiovascular diseases (cvd). the purposes of the study are as follows: 1. to elucidate characteristics of patients with overt hf and the associated prognostic risks 2. to elucidate characteristics of patients at risk for hf and the factors associated with cvd progression 3. to elucidate factors associated with the development of ahfs 4. to elucidate prevalence and prognostic impact of metabolic syndrome (mets) in patients with overt hf 5. to elucidate the association between mets and the development of ahfs 6. to elucidate the prevalence and prognostic impact of malignancy in patients with cvd 7. to elucidate the prevalence of patients needing home nursing care and the characteristics of bedridden patients with cvd.

Eligibility criteria:
inclusion criteria: * structural heart disease but without signs or symptoms of heart failure. * structural heart disease with prior or current symptoms of heart failure. * refractory heart failure requiring specialized interventions. * patients with prior cardiovascular surgery or percutaneous coronary intervention and those who need such interventions. exclusion criteria: * patients with age\<20 years old. * patients who refused to participate.